Midwest Cardiovascular Research Foundation, 1622 E. Lombard Street, Davenport, IA 52803 USA.
J Invasive Cardiol. 2020 Aug;32(8):289-294. doi: 10.25270/jic/20.00192.
We present the results of a patient-level meta-analysis of the two currently completed and core-lab adjudicated prospective trials of Jetstream atherectomy system (Boston Scientific) in femoropopliteal in-stent restenosis (FP-ISR) and compare the findings to a published, prespecified 6-month performance goal of target-lesion revascularization (TLR) with angioplasty alone.
The JETSTREAM-ISR (n = 29 patients; n = 32 lesions) was a two-center feasibility study that evaluated Jetstream atherectomy in FP-ISR. The JET-ISR (n = 60 patients; n = 60 lesions) was a 10-center investigational device exemption study that evaluated the same. Both trials were investigator-initiated, prospective, single-arm designs, with core lab assessments of stent-device interaction and with nearly identical inclusion/exclusion criteria and data definitions. The primary endpoint was TLR, which was analyzed using proportional and Kaplan-Meier analyses.
A total of 92 lesions were treated in 89 patients. Kaplan-Meier freedom from TLR at 6 months was 78.5% (95% confidence interval, 69.9-87.1). Proportional TLR was 21.2% (18/85 limbs). The performance goal of TLR (bailout stent included as TLR) was set at 37.9% at 6 months with balloon angioplasty alone. TLR rate derived from the meta-analysis was significantly lower than the TLR rate set for the historic control accounting for the 95% confidence interval lower bound (P<.01). There was no device-stent interaction and no amputation. Distal embolization occurred in 11/92 (12.0%) (filters used in 76.1% of all cases) and bailout stenting was performed in 8.7%.
In this meta-analysis, Jetstream atherectomy in treating FP-ISR had a high freedom from TLR despite no adjunctive drug-coated balloon use. Randomized trials are needed to confirm these findings.
我们呈现了目前已完成的两项经核心实验室裁定的前瞻性 Jetstream 旋切系统治疗股腘动脉支架内再狭窄（FP-ISR）的患者水平荟萃分析结果，并将这些发现与单独使用血管成形术的预定 6 个月靶病变血运重建（TLR）的既定目标进行了比较。
JETSTREAM-ISR（n=29 例患者；n=32 处病变）是一项在 FP-ISR 中评估 Jetstream 旋切术的双中心可行性研究。JET-ISR（n=60 例患者；n=60 处病变）是一项评估相同器械的 10 中心研究性器械豁免研究。这两项试验均由研究者发起、前瞻性、单臂设计，对支架-器械相互作用进行核心实验室评估，且具有几乎相同的纳入/排除标准和数据定义。主要终点是 TLR，使用比例和 Kaplan-Meier 分析进行分析。
共有 89 例患者的 92 处病变接受了治疗。6 个月时 TLR 的 Kaplan-Meier 无事件生存率为 78.5%（95%置信区间，69.9-87.1）。比例 TLR 为 21.2%（18/85 肢体）。单独使用球囊血管成形术时，6 个月时 TLR 的目标值（包括挽救性支架）设定为 37.9%。从荟萃分析得出的 TLR 率明显低于历史对照的 TLR 率，考虑到 95%置信区间下限（P<.01）。无器械-支架相互作用和截肢。92 处病变中有 11 处（12.0%）发生远端栓塞（所有病例中 76.1%使用了过滤器），并进行了挽救性支架置入。
在这项荟萃分析中，尽管未使用药物涂层球囊，Jetstream 旋切术治疗 FP-ISR 仍具有较高的 TLR 无事件生存率。需要进行随机试验来证实这些发现。
